Synergy Disc Instruments
FDA 510(k) K253392 · Synergy Spine Solutions, Inc.
510(k) numberK253392
Submission
- Device name
- Synergy Disc Instruments
- Applicant
- Synergy Spine Solutions, Inc.
Louisville, CO, US - Received
- September 30, 2025
- Decision date
- March 27, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QLQ – Manual Instruments Designed For Use With Total Disc Replacement Devices
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.4515
- Specialty
- Orthopedic
The devices are intended to manipulate tissue or implant materials for the positioning, alignment, defect creation, placement, or removal of total disc replacement devices.
Other 510(k)s with product code QLQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262639 | BAGUERA® C Cervical Disc Surgical InstrumentsQLQ · Traditional | Spineart SA | 08/14/2026SE |
| K250554 | prodisc® L InstrumentsQLQ · Traditional | Centinel Spine, LLC | 04/25/2025SE |
| K242869 | prodisc® L InstrumentsQLQ · Traditional | Centinel Spine, LLC | 12/17/2024SE |
| K241117 | M6-C Single Use, Disposable InstrumentationQLQ · Traditional | Spinal Kinetics / Orthofix / Seaspine | 06/21/2024SE |
| K231769 | activL® Next Generation InstrumentationQLQ · Special | Aesculap Implants Systems, LLC | 07/13/2023SE |
| K221848 | prodisc C SK, prodisc C Nova, and prodisc C Vivo InstrumentsQLQ · Traditional | Centinel Spine, LLC | 08/19/2022SE |
| K220861 | M6-C Artificial Cervical Disc Instruments ASQLQ · Traditional | Spinal Kinetics, LLC | 06/02/2022SE |
| K211757 | Simplify DiscQLQ · Traditional | Nuvasive, Inc. | 08/20/2021SE |
Questions and answers
When was Synergy Disc Instruments cleared by the FDA?
Synergy Disc Instruments (K253392) received a 510(k) decision of Substantially Equivalent on March 27, 2026, 178 days after the submission was received.
What is the product code of K253392?
The FDA product code is QLQ – Manual Instruments Designed For Use With Total Disc Replacement Devices, a Class II (moderate risk) device regulated under 21 CFR 888.4515.